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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TEOXANE SA TEOSYAL RHA 4 DERMAL FILLER

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TEOXANE SA TEOSYAL RHA 4 DERMAL FILLER Back to Search Results
Lot Number TPUL-212426A0
Device Problem Improper or Incorrect Procedure or Method (2017)
Patient Problem Skin Infection (4544)
Event Date 02/09/2022
Event Type  Injury  
Manufacturer Narrative
Additional mfr narrative: data batch review: the batch data review was compliant with the applicable specifications. No element allows us to identify a defect in either the quality or the safety of this teosyal rha 4 (tpul-212426a0) product. Data batch history: no other complaint was registered to date ((b)(6)2022) with this batch number.
 
Event Description
This case occurred outside of the usa, in (b)(6). According to information as of (b)(6) 2022, a patient was injected on (b)(6)2022, with 2 ml of teosyal puresense ultra deep (tsul-212223b0) into the bilateral palpebromalar and nasojugal groove (object of the complaint(b)(4)), and with 1 ml of teosyal rha 4 (tpul-212426a0) into the bilateral nasolabial folds (object of this complaint). Two days later, the patient presented with inflammation and skin induration on the right nasolabial fold, and as a corrective action, she received antibiotic treatment. Following receipt of this complaint, a local medical expert was put in contact with the physician to advise on this case. On feb. 16, 2022, we were informed that the patient being suffering from an autoimmune disease (psoriasis), the medical expert suspected the presence of the local infection, and subsequently, he prescribed a combined antibiotic treatment (augmentin and ciprofoxacine for 7 days). On feb. 22, 2022, we were informed that in addition to the pathology of psoriasis, the patient also suffered from diabetes, and for this purpose, she was hospitalized to receive appropriate antibiotic treatment against the local infection. According to our latest information on (b)(6) 2022, the symptoms have completely subsided, the patient was fine, only a small scar presented on the affected area which according to the physician will have disappeared without further complication.
 
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Brand NameTEOSYAL RHA 4
Type of DeviceDERMAL FILLER
Manufacturer (Section D)
TEOXANE SA
rue de lyon
105
geneva 1203
CH 1203
Manufacturer (Section G)
TEOXANE SA
rue de lyon
105
geneva 1203
CH 1203
Manufacturer Contact
nicolas caill
rue de lyon
105
geneva 1203
CH   1203
022344-963
MDR Report Key13711746
MDR Text Key286863720
Report Number3005975625-2022-00077
Device Sequence Number1
Product Code LMH
Combination Product (y/n)N
Reporter Country CodeES
PMA/PMN Number
P170002,
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 03/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberTPUL-212426A0
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/30/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/09/2022 Patient Sequence Number: 1
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